At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Unblinded Quasi-Randomized Pilot Study Exploring the Benefits of the ZeroG TRiP System to Improve Patient Balance Following an Acute Stroke
In Brief
A clinical study evaluating Body weight support system control group and Body weight support system with balance perturbations for Stroke and Balance; Distorted. Completed, enrolled 32 participants across 1 site.
Detailed Summary
Strokes are neurological events that can lead to devastating physical and cognitive deficits, such as the inability to ambulate, impaired balance regulation, and loss of coordination. Due to the physical and cognitive deficits experienced following a stroke, many require admission to an inpatient rehabilitation facility to maximize their independence before returning to the home setting. The ability to walk, stand, climb stairs, and other mobility-related functional tasks, are critical components of achieving this functional independence. However, it is often difficult for post-stroke patients with balance impairments to safely practice balance and gait training without putting both therapists and patients at risk for injury. Incorporating robotic technologies to neurological rehabilitation can play a critical role in delivering safe and effective gait and balance therapy. Body-weight support systems (BWSSs) unload paretic lower limbs, patients with gait impairments can practice a higher repetition of steps in a safe, controlled manner. As participants perform gait training, these systems support the participant's body-weight, permitting those with excessive weakness and poor coordination, to ambulate and perform more intensive therapy sessions sooner in their recovery, with minimal risk injurious fall. In addition to BWSSs, balance perturbation systems, which purposefully unbalance participants so to rehabilitate their postural control, have been used to improve gait and balance-control after stroke, or other age and disease related balance impairments. The goal of this study was to evaluate the efficacy of a recently developed, not yet reported, balance perturbation module for the ZeroG BWSS. This new balance perturbation training module is directly integrated into the ZeroG BWSS and allows for the direct induction of safe lateral, anterior, and/or posterior perturbations via a Wi-Fi-enabled handheld device. During both stationary and ambulatory activities, this system was used unbalance participants in order to train their balance-control and balance-reactions. The purpose of this pilot study was to determine if this newly developed BWSS balance perturbation system more effectively rehabilitates participant gait and balance after stroke than the standard BWSS protocol without perturbations.
Study Details
Timeline
Interventions
The BWSS control group interventions consisted of various balance activities, including: marching, side-stepping, retro-ambulation, step-taps, and step-ups. The BWSS control group also practiced various gait tasks, including: ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.
The BWSS with balance perturbations group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.In addition, this arm will receive eight balance perturbations, two in each direction (lateral, anterior, and posterior) each session. BWSS-P participants will start at perturbation level "one" and progress up to level "ten" as appropriate. Each session, the perturbation level will be set based on the participant's progress.